Senior QA Lead, Pharmaceuticals (Hybrid)

Placements24; East London; Hybrid; ZAR 900,000 - 1,500,000; Full time

Job summary

Placements24 represents a prominent pharmaceutical company in East London, Eastern Cape, seeking a Lead Quality Assurance Specialist. This senior role oversees QA operations, leads a team of QA professionals, and drives QMS implementation to meet GMP and regulatory requirements.

You will manage deviations, CAPAs, change control, batch records review, and internal audits, while collaborating with production, R&D, and regulatory affairs to maintain product quality and compliance.

Qualifications

• Senior QA leadership experience in pharma.
• Strong knowledge of GMP and SAHPRA/FDA regulations.
• Proven ability to develop and implement QMS, SOPs, audits and CAPA.

Responsibilities

• Develop, implement and maintain Quality Management Systems (QMS) in line with GMP/regulatory guidelines.
• Lead and mentor the QA team, providing guidance on QA procedures and best practices.
• Oversee review/approval of batch records, validation protocols, and critical quality documentation.
• Conduct internal audits and support regulatory inspections (e.g., SAHPRA).
• Manage deviations, CAPAs, and change control processes.
• Collaborate with production, R&D, and regulatory affairs to resolve quality issues.
• Monitor and report on key quality metrics and drive improvements.
• Ensure compliance with local and international pharmaceutical regulations.
• Stay updated on evolving regulatory landscapes and implement changes.

Skills

Leadership

Quality Assurance

GMP

Regulatory compliance

QMS

CAPA

SOPs

Audits

Education

Bachelor's degree in Pharmacy/Chemistry/Biology

Tools

QMS software

Job description

Placements24 represents a prominent pharmaceutical company in East London, Eastern Cape, seeking a Lead Quality Assurance Specialist. This senior role oversees QA operations, leads a team of QA professionals, and drives QMS implementation to meet GMP and regulatory requirements.

You will manage deviations, CAPAs, change control, batch records review, and internal audits, while collaborating with production, R&D, and regulatory affairs to maintain product quality and compliance.